Greenbaum J, Leznoff A, Schulz J, Mazza J, Tobe A, Miller D
Syntex Inc, Mississauga, Ontario, Canada.
Ann Allergy. 1988 Oct;61(4):305-10.
This double-blind, randomized, crossover study compared the incidence of nasal burning and stinging, as well as overall tolerability of the currently marketed formulation of Rhinalar (original formulation) to a new formulation of Rhinalar containing less propylene glycol. In addition, patient and investigator subjective evaluations were used to compare the effectiveness of the test medications in controlling the nasal symptoms of seasonal allergic rhinitis. A total of 122 patients were enrolled in this 4-week trial. Each patient received one formulation of Rhinalar for 2 weeks and then crossed over to receive the alternate formulation for an additional 2 weeks. Eighteen patients withdrew from the trial prematurely. Ten patients were lost to follow-up and eight withdrew due to side effects and/or inadequate therapeutic response. Statistical comparisons of patient evaluations of nasal burning and stinging with the two formulations of Rhinalar showed a very significant difference in terms of severity (P less than .001), duration (P less than .001), and tolerability (P = .006) in favour of the new formulation. A reduction in severity of throat irritation with the new formulation was also shown to be statistically significant (P = .006). Nausea, headache, and other side effects including watery eyes, taste perversion, and runny nose were seldom reported with either test medication. Both formulations were shown to be equally effective in relieving the nasal symptoms of seasonal allergic rhinitis. The considerable reduction in nasal burning and stinging and throat irritation with the new formulation of Rhinalar was shown to enhance patient acceptability and may lead to better compliance.
这项双盲、随机、交叉研究比较了现售的雷诺考特制剂（原制剂）与含丙二醇较少的雷诺考特新制剂的鼻烧灼感和刺痛感发生率，以及总体耐受性。此外，还采用了患者和研究者的主观评估来比较受试药物在控制季节性变应性鼻炎鼻症状方面的有效性。共有122例患者纳入了这项为期4周的试验。每位患者接受一种雷诺考特制剂治疗2周，然后交叉接受另一种制剂再治疗2周。18例患者提前退出试验。10例患者失访，8例因副作用和/或治疗反应不佳而退出。对两种雷诺考特制剂的鼻烧灼感和刺痛感的患者评估进行统计学比较，结果显示在严重程度（P<0.001）、持续时间（P<0.001）和耐受性（P = 0.006）方面存在非常显著的差异，新制剂更具优势。新制剂导致的咽喉刺激严重程度降低也具有统计学意义（P = 0.006）。两种受试药物很少报告恶心、头痛和其他副作用，包括流泪、味觉异常和流涕。两种制剂在缓解季节性变应性鼻炎鼻症状方面均显示出同等疗效。雷诺考特新制剂在鼻烧灼感、刺痛感和咽喉刺激方面的显著降低表明其可提高患者的接受度，并可能带来更好的依从性。
